Osteomed Recalls Osteovation Bone Void Filler Kits Due to Shelf-Life Error
Osteomed, LLC is recalling Osteovation 10 CC Impact Formula bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a labeling error regarding shelf-life which may affect product performance (setting characteristics), but no injuries, illnesses, or deaths are reported in the source text.
Plain-English summary
Osteomed, LLC is recalling 995 units of Osteovation 10 CC Impact Formula bone void filler kits. The product is a medical device used to fill bone voids, which is replaced by bone during the healing process. The recall involves specific lot numbers: 17051914, 17060506, 1127991, 1128827, 1132180, 1132479, 1134902, and 1142212.
The reason for the recall is an incorrect shelf-life label on the kits. The source text states that the product may not maintain its setting characteristics for the duration of the labeled shelf-life. This means the product could fail to set properly if used after the printed expiration date, potentially compromising the intended medical outcome.
The affected units were distributed worldwide, including nationwide in the United States and in Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand. Healthcare providers and patients who have received these specific kits should stop using them and contact Osteomed, LLC or their supplier for instructions on return or replacement.
The recalled product
- Product
- OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Affected units
- 995
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- LOT 17051914
- 17060506
- 1127991
- 1128827
- 1132180
- 1132479
- 1134902 and 1142212
Distribution
Part of a larger recall action
This product is one of 12 recalled by Osteomed, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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